Treatment Outcome in Eating Disorders

Children's Hospitals and Clinics of Minnesota

Status: Completed

Conditions: Eating Disorder

Treatments: Behavioral: FBT + UP for ARFID; Behavioral: Enhanced Cognitive behavioral therapy; Behavioral: Family-based treatment modified for ARFID; Behavioral: Family-based treatment

Study type: Observational

Funder types: Other

Identifiers

NCT03599921

47919

Details and patient eligibility

About

Do the current eating disorder treatments, i.e., Family-based Treatment (FBT) and Enhanced Cognitive behavioral therapy (CBT-E), offered at the Center for the Treatment of Eating Disorders (CTED) demonstrate effectiveness? Specifically, which type of treatment is most effective for which diagnoses? Participants with Anorexia Nervosa (AN), Bulimia Nervosa (BN), Other Specified Feeding or Eating Disorder (OSFED), or Unspecified Feeding or Eating Disorder (UFED) in this study will self select one of the two treatment groups, FBT or CBT-E.

Additionally, does Family-based Treatment (FBT) modified for Avoidant/Restrictive Food Intake Disorder (ARFID) and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) demonstrate effectiveness for patients with an Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis?

Full description

Given a significant number of patients who presented for treatment at the Center for the Treatment of Eating Disorders (CTED) and were enrolled in this effectiveness study met criteria for a diagnosis of Avoidant/Restrictive Food Intake Disorder (ARFID), and because there are currently no randomized control trials systematically evaluating children/adolescents with ARFID, a secondary aim was added to this study.

The secondary aim will evaluate the preliminary effectiveness of two treatment groups including: Family-based Treatment (FBT) modified for ARFID and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) for ARFID patients.

Enrollment: 275 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be at least 6 years of age, attending the CTED clinic for outpatient treatment of a Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosed eating disorder in order to be included in this study.

Exclusion criteria

• Participants who are receiving inpatient services only and will not return to CTED for outpatient treatment.
• Participants with a co-morbid medical disorder known to influence eating or weight.
• Participants presenting with a significant psychotic disorder.
• Participants who are acutely suicidal.
• Participants who demonstrate significant substance abuse and/or substance dependence.

Trial design

275 participants in 4 patient groups

Family-based Treatment

Description:

Participants will receive family-based treatment.

Treatment:

Behavioral: Family-based treatment

Enhanced Cognitive behavioral therapy

Description:

Participants will receive enhance cognitive behavioral therapy.

Treatment:

Behavioral: Enhanced Cognitive behavioral therapy

Family-based Treatment for ARFID

Description:

Participants will receive family-based treatment modified for Avoidant/Restrictive Food Intake Disorder (ARFID).

Treatment:

Behavioral: Family-based treatment modified for ARFID

FBT + UP for ARFID

Description:

Participants will receive family-based treatment with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents, named FBT + UP for ARFID.

Treatment:

Behavioral: FBT + UP for ARFID